Charm Tex Fluoride Gel Paste, Dentifrice
NDC Package 71035-002-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Charm Tex Fluoride Gel (sodium fluoride) pastes is adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowingChildren under 2 years: Ask a dentist or physician. This formulation utilizes a paste, dentifrice delivery system. Marketed by Yangzhou Hongshengding Chemical Co.,ltd., this product is identified by NDC 71035-002 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
71035-002-01
Package Description
1000 TUBE in 1 PACKAGE / 7.1 g in 1 TUBE
Product Code
71035-002
11-Digit Billing Format
71035000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Charm Tex Fluoride Gel
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SODIUM FLUORIDE .1 g/100g
Usage Information
Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowingChildren under 2 years: Ask a dentist or physician

Regulatory & Marketing

Labeler Name
Yangzhou Hongshengding Chemical Co.,ltd.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-13-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71035-002). Click a package code to view its specific billing and regulatory data.

71035-002-02
720 TUBE in 1 PACKAGE / 17 g in 1 TUBE
71035-002-03
720 TUBE in 1 PACKAGE / 24 g in 1 TUBE
71035-002-04
144 TUBE in 1 PACKAGE / 43 g in 1 TUBE
71035-002-05
144 TUBE in 1 PACKAGE / 78 g in 1 TUBE
71035-002-06
60 TUBE in 1 PACKAGE / 130 g in 1 TUBE
71035-002-07
60 TUBE in 1 PACKAGE / 181 g in 1 TUBE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71035-002-01 identifies a specific commercial package of 1000 tube in 1 package / 7.1 g in 1 tube of Charm Tex Fluoride Gel, a human over the counter drug labeled by Yangzhou Hongshengding Chemical Co.,ltd.. This paste, dentifrice is formulated for topical use and contains sodium fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Yangzhou Hongshengding Chemical Co.,ltd. on June 13, 2025. The current certification is valid through December 31, 2026.

How is this Yangzhou Hongshengding Chemical Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71035000201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71035-002-01
11-Digit CMS (5-4-2)
71035-0002-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.